The Biostatistics Center (BSC) of the Milken Institute School of Public Health is an off-campus research facility of The George Washington University located in Rockville, Maryland. The BSC serves as the coordinating center for large scale multi-center clinical trials and epidemiological studies funded by federal agencies including the National Institutes of Health (NIH). The BSC is a leader in the statistical coordination of major medical research programs of national and international scope. Visit our website at: www.bsc.gwu.edu.
The Biostatistics Center is seeking a Research Associate to work independently as well as with a research team that serves as the coordinating center for a study in type 2 diabetes: the Glycemia Reduction Approaches In Diabetes: A Comparative Effectiveness Study (GRADE). A Research Associate carries out research and development activities and while utilizing both technical and research experience; acts as liaison with subcommittees and working groups and interacts with programmers to develop study reports. The individual is a proactive critical thinker with strong communication, technical and organizational skills. The position works under general supervision. A certain degree of creativity and latitude is required.
Job duties of the Research Associate position include:
- Coordinates regulatory and compliance activities of clinical sites for all activities. Ensures all new processes and procedures, as well as quality assurance activities of the Study are properly implemented and documented. Ensures complete and current approvals for sites are maintained at the Coordinating Center and timely completion of reviews.
- Provides day-to-day clinical center oversight on issues including data management and quality; develops and circulates study participant and site level reports, as well as training and certification pertaining to Study protocol.
- Provides guidance on organization and troubleshooting to Coordinating Center research team on documentation, tracking and resolution of issues. Provides staff training, and transfers technical expertise.
- Maintains study manuals, FAQs, SOPs, and coordinates regular releases throughout the year. Prepares new study manuals as assigned. Coordinates updates and releases with central units as needed for manuals and study procedures.
- Compiles and maintains documentation of study issues regarding data management, safety monitoring logs, study protocol deviations, etc. Identifies and documents site and central unit performance issues, present issues to study leadership as needed.
- Creates comprehensive workflows and checklists for internal Study processes. Ensures accurate completion of tasks and confirms accountable staff have completed the checklist or similar documentation for tracking.
- Facilitates form maintenance tasks including making approved changes to study forms, training clinical centers on forms and procedural updates, revising data management and Quality Control (QC) queries as needed.
- Serves as Coordinating Center liaison to assigned subcommittees and work groups. Performs coordination of study activities (e.g. calls, meeting, etc.), works collaboratively with chairs and Coordinating Center (CoC) leadership to develop agendas and follows up on action items and preparation of reports.
- Collaborates in the development and maintenance of study policies and standard operating procedures for the execution of key responsibilities and tasks pertaining to the study. Works on final study documentation and archival, as required.
- Manages the planning of study meetings and various staff trainings (including agenda, logistics, minutes, and implementation support) and Steering Committee meetings.
- Oversees the posting and organization of content of study private and public websites, which provide access to documents and information required by investigators, research staff, safety monitors/RACC, and the general public. Maintains the ClinicalTrials.gov website content.
- Coordinates with central units as assigned to include calls, issue identification and resolution/follow-up, documentation of issues or coordination with CoC. Supports substudies as assigned.
- Maintains intermittent communication with the Biostatistics Center Systems Support staff and Administrative staff relating to systems and administrative details according to Study needs.
- Participates in site visits and prepares site visit reports and follows up on issues for resolution as required.
- Performs other work related duties as assigned. The omission of specific duties does not preclude the supervisor from assigning duties that are logically related to the position.
Qualified candidates will hold a master’s degree and 1 year of experience in a related discipline. Degree must be conferred by the start date of the position.
-Working knowledge of MySQL, CSS and SAS.
-Proficient in Microsoft Office applications.